DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Terrats Medical SL â„… Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
August 8, 2017
Re: K170588 Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 6, 2017 Received: July 7, 2017
Dear Linda Schulz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2 - Linda Schulz
K170588
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely,
Mary S. Runner -S for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
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510(k) Summary Page 1 of 6
K170588 - DESS Dental Smart Solutions
510(k) Summary Terrats Medical SL DESS Dental Smart Solutions K170588 August 8, 2017
ADMINISTRATIVE INFORMATION Manufacturer Name
Terrats Medical SL Avenida La Ferrería (Pol Ind La Ferrería) 62 Montcada i Reixac, 08110 Spain Telephone +34 93 564 60 06 Fax +34 93 564 73 17
Official Contact
Roger Terrats, COO
Representative/Consultant
Linda Schulz, BSDH, RDH Kevin Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1-858-792-1235 Fax: +1-858-792-1236 Email: LSchulz@paxmed.com KThomas@paxmed.com
DEVICE NAME AND CLASSIFICATION Trade/Proprietary Name DESS Dental Smart Solutions Common Name Dental implant abutment Classification Name Endosseous dental implant abutment Classification Regulations 21 CFR 872.3630, Class II Product Code NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K120414, OsseoSpeed™ Plus, Astra Tech AB Reference Predicates K072878, Modification to: Locator Implant Anchor, Zest Anchors, Inc. K092341, Low Profile Abutment, Biomet 3i K150203, Medentika CAD/CAM Abutments, Medentika GmbH K150367, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA
510(k) Summary Page 2 of 6
K170588 - DESS Dental Smart Solutions
Compatible Implant System Predicates K063341 K063286
3i OSSEOTITE Certain® Dental Implants ®
OSSEOTITE Dental Implants TM
K101732
OsseoSpeed
K073075
FRIADENT Implant Systems
Implant Innovations, Inc. Implant Innovations, Inc. Astra Tech AB
®
K142260
NobelActive
K073142
NobelReplace Hexagonal Implants
DENTSPLY International, Inc. Nobel Biocare AB
®
Nobel Biocare AB
K050705
TiUnite Implants
Nobel Biocare AB
K050406
NOBELSPEEDY™ Implants
Nobel Biocare USA LLC
K022562
Various Brånemark System Implants – Immediate Function Indication
Nobel Biocare AB
K140878
Straumann® Bone Level Tapered Implants
Straumann USA, LLC
K062129
P.004 Implants
Institut Straumann AG
®
K130222
Straumann Dental Implant System SLActive and Roxolid Product Families
Straumann USA, LLC
K112160
Tapered Screw-Vent® X Implant
Zimmer Dental, Incorporated
INDICATIONS FOR USE DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems Implant System Compatibility 3i Certain® 3i OSSEOTITE® OsseoSpeedTM FRIADENT XiVE NobelActive® NobelReplace Conical Nobel Replace Trilobe Brånemark Straumann® Bone Level Straumann® Tissue Level Tapered Screw-Vent®
Implant Diameter (mm) 3.25, 4.0, 5.0 3.25, 3.75, 4.0, 5.0 3.5, 4.0, 5.0 3.4, 3.8, 4.5 3.5, 4.3, 5.0 3.5, 4.3, 5.0 3.5, 4.3, 5.0 3.5, 3.75/4.0, 5.0 3.3, 4.1, 4.8 3.3, 4.1, 4.8 3.7, 4.1, 4.7, 6.0
Platform Diameter (mm) 3.4, 4.1, 5.0 3.4, 4.1, 5.0 3.5/4.0, 4.5/5.0 3.4, 3.8, 4.5 NP, RP NP, RP NP, RP, WP NP, RP, WP NC, RC RN, WN 3.5, 4.5, 5.7
DEVICE DESCRIPTION
DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. The following table outlines the body and platform diameters by abutment design and corresponding implant line.
DESS Abutment System
Internal Hex USA
Octagon
Conical BL
External Hex Universal
Tri-Lobe
Active Hex
Internal Hex FD
Internal Hex Conic
External Hex USA
Internal Hex “Click”
Temporary Non-Engaging NP RP WP NP RP WP RP WP NP RP WP NP RP NP RP WP NP RP WP NC RC RN WN NP RP WP
Healing NP 3.4 RP 4.1 WP 5.0 NP 3.4 RP 4.1 WP 5.0 RP 3.5/4.0 WP 4.5/5.0 NP 3.4 RP 3.8 WP 4.5 NP 3.5 RP 3.9 NP 3.5 RP 4.3 WP 5.0 NP 3.5 RP 4.1 WP 5.1 NC 3.3 RC 4.1 RN 4.8 WN 6.5 NP 3.4 RP 4.5 WP 5.7
Temporary Engaging RN WN NP RP WP
NP RP WP NP RP WP NC RC
NP RP
NP RP WP NP RP WP RP WP NP RP WP
Straight NP RP WP
RN
NP RP WP NP RP WP NC RC
NP RP
NP RP WP NP RP WP RP WP NP RP WP
Ti Base Non-Engaging RN WN NP RP WP
NP RP WP NP RP WP NC RC
NP RP
NP RP WP NP RP WP RP WP NP RP WP
Ti Base Engaging RN WN NP RP WP
NP RP WP NP RP WP NC RC
NP RP
NP RP WP NP RP WP RP WP NP RP WP
NP RP
RN
NC RC
NC RC RN WN NP RP WP
NP RP
NP RP
NP RP
NP RP
RN WN
NP RP WP NP RP WP NC RC
NP RP
OsseoSpeedTM 3.5/4.0 (RP), 4.5/5.0 (WP)
RP WP
Tapered Screw-Vent 3.4 (NP), 4.5 (RP), 5.7 (WP)
Straumann® Tissue Level RN (4.8), WN (6.5)
Straumann® Bone Level NC (3.3), RC (4.1)
Brånemark System® NP (3.5), RP (4.1), WP (5.1)
NobelReplace® Trilobe NP (3.5), RP (4.3), WP (5.0)
NobelActive® NP (3.5), RP (3.9) NobelReplace® Conical NP (3.5), RP (3.9)
FRIADENT XiVE® 3.4 (NP), 3.8 (RP), 4.5 (WP)
3i OSSEOTITE® 3.4 (NP), 4.1(RP), 5.0 (WP)
NP RP
NP
NP RP WP
3i Certain® 3.4 (NP), 4.1 (RP), 5.0 (WP)
OEM Implant System
NP RP
RP WP
NP RP WP
NP RP
NP RP WP NP RP WP RP WP
Pre-milled Blank Engaging
Summary of Abutment Designs
K170588 - DESS Dental Smart Solutions
DESS LOC
510(k) Summary Page 3 of 6
Multi-Unit
510(k) Summary Page 4 of 6
K170588 - DESS Dental Smart Solutions
Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile. PERFORMANCE DATA Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation to an SAL of 10-6 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device; biological evaluation according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 for all surfaces to demonstrate that all devices are non-cytotoxic; SEM evaluation and measurement of the ZrN and SelectGrip surfaces to demonstrate suitability of the surface; and engineering and dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment fixation screws to confirm compatibility. No clinical data were included in this submission. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices. Comparison of Indications for Use Statements Indications for Use Statement Subject Device DESS Dental Smart Solutions Terrats Medical SL
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems Implant System Compatibility Implant Diameter (mm) Platform Diameter (mm) 3i Certain® 3.25, 4.0, 5.0 3.4, 4.1, 5.0 3i OSSEOTITE® 3.25, 3.75, 4.0, 5.0 3.4, 4.1, 5.0 OsseoSpeedTM 3.5, 4.0, 5.0 3.5/4.0, 4.5/5.0 FRIADENT XiVE 3.4, 3.8, 4.5 3.4, 3.8, 4.5 NobelActive® 3.5, 4.3, 5.0 NP, RP NobelReplace Conical 3.5, 4.3, 5.0 NP, RP Nobel Replace Trilobe 3.5, 4.3, 5.0 NP, RP, WP Brånemark 3.5, 3.75/4.0, 5.0 NP, RP, WP Straumann® Bone Level 3.3, 4.1, 4.8 NC, RC Straumann® Tissue Level 3.3, 4.1, 4.8 RN, WN Tapered Screw-Vent® 3.7, 4.1, 4.7, 6.0 3.5, 4.5, 5.7
510(k) Summary Page 5 of 6
K170588 - DESS Dental Smart Solutions
Indications for Use Statement Primary Predicate Device K120414 OsseoSpeed™ Plus Astra Tech AB
Reference Predicate Devices K072878 Modification to: Locator Implant Anchor Zest Anchors, Inc. K092341 Low Profile Abutment Biomet 3i, Inc. K150203 Medentika CAD/CAM Abutments Medentika GmbH
Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Atlantis Abutments: The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Not available
Biomet 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment. Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Implant System Compatibility
Series
Implant Diameter (mm)
Platform Diameter (mm)
Nobel Biocare Replace™ Select
E
3.5, 4.3, 5.0, 6.0
3.5, 4.3, 5.0, 6.0
Nobel Biocare NobelActive™
F
3.0, 3.5, 4.3, 5.0
3.0, 3.5, 3.9 (4.3), 3.9 (5.0)
Biomet 3i Osseotite® Certain®
H
3.25, 4.0, 5.0
3.4, 4.1, 5.0
I
3.25, 3.75, 4.0, 5.0
3.4, 4.1, 5.0 3.5, 4.1, 4.1, 5.1
®
Biomet 3i Osseotite
K
3.3, 3.75, 4.0, 5.0
Straumann Bone Level
L
3.3, 4.1, 4.8
3.3, 4.1, 4.8
Straumann Standard
N
3.3, 4.1, 4.8
3.5( NNC), 4.8, 6.5
Zimmer Tapered Screw-vent®
R
3.3, 3.7, 4.1, 4.7, 6.0
3.5, 4.5, 5.7
Astra Tech OsseoSpeed™
S
3.0, 3.5, 4.0, 4.5, 5.0
3.0, 3.5, 4.0, 4.5, 5.0
Dentsply Friadent® Frialit/XiVE®
T
3.4, 3.8, 4.5, 5.5
3.4, 3.8, 4.5, 5.5
Nobel Biocare Brånemark
Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. K150367 Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized Neodent Implant prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or System multi-unit restorations, or screw-retained single restorations. JJGC Indústria e PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental Comércio de implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained Materiais Dentários single restorations or cement-retained single or multi-unit restorations. SA
510(k) Summary Page 6 of 6
K170588 - DESS Dental Smart Solutions Comparison of Technological Characteristics Subject Device
Design Prosthesis Attachment Restoration Abutment Platform Diameter (mm) Abutment Angle Abutment/Implant Interface Material Abutment
Reference Predicates K072878
K092341
K150203
K150367
DESS Dental Smart Solutions
OsseoSpeed™ Plus
Modification to: Locator Implant Anchor
Low Profile Abutment
Medentika CAD/CAM Abutments
Neodent Implant System
Terrats Medical SL
Astra Tech AB
Zest Anchors, Inc.
Biomet 3i, Inc.
Medentika GmbH
JJGC Indústria e Comércio de Materiais Dentários SA
Cement-retained Screw-retained Single-unit Multi-unit
Cement-retained Screw-retained Single-unit Multi-unit
Overdenture attachment
Screw-retained
Overdenture
Single-unit Multi-unit
Cementretained Single-unit Multi-unit
Cement-retained Screw-retained Single-unit Multi-unit
3.4 – 5.7
3.0 – 5.4
2.5 – 6.5
3.4 – 5.0
3.0 – 7.0
3.0 – 6.0
Straight Internal, External
Straight to 30°
Straight Internal, External
Straight to 30° Internal, External
Straight to 30°
Internal
Straight to 30° Internal, External
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V
Ti-6Al-4V Screw
Primary Predicate K120414
Ti-6Al-4V
Ti-6Al-4V Zirconia, Gold, PEEK Ti-6Al-4V
Internal
DESS Dental Smart Solutions abutments are substantially equivalent in design, function, material, size, and Indications for Use to OsseoSpeed Plus (K120414) and Medentika CAD/CAM Abutments (K150203). All are intended for use with endosseous dental implants in the maxilla and mandible to provide prosthetic support. Digital files for DESS Dental Smart Solutions abutments and for Medentika CAD/CAM Abutments are to be sent to a validated milling center for manufacture. Differences in the type of restoration named or specific milling center stated in the Indications for Use statement do not affect the intended use. Subject device abutment designs and function are substantially equivalent to design and function of abutments included in K120414, K072878, K092341, K150203 and K150367. Implant/abutment interface compatibility for the subject device is substantially equivalent to the compatible implant system predicates listed above.
CONCLUSION The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.